Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-26 @ 7:37 PM
Study NCT ID:
NCT05532904
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2022-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID)
Sponsor:
Organization:
Raw JSON
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Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'at 3 Months', 'description': 'SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaireTwo summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12)'}, {'measure': 'Fatigue', 'timeFrame': 'at 3 months, 6 months', 'description': "Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue"}, {'measure': 'Dyspnea', 'timeFrame': 'at 3 months, 6 months', 'description': 'Borg scale (0 min-10 max)'}, {'measure': 'Cognitive complaint', 'timeFrame': 'at 3 months, 6 months', 'description': 'Mac Nair \\& Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version'}, {'measure': 'Pain', 'timeFrame': 'at 3 months, 6 months', 'description': 'Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain)'}, {'measure': "Patient's satisfaction", 'timeFrame': 'at 3 months, 6 months', 'description': 'Ad hoc questionnaire'}, {'measure': 'Physical fitness', 'timeFrame': 'at inclusion, 3 months, 6 months', 'description': 'Global physical activity questionnaire (GPAQ) score'}, {'measure': 'Post-effort heart rate', 'timeFrame': 'at inclusion, 3 months, 6 months', 'description': 'Difference between estimated and measured heart rate (HR) at the end of the walking test'}, {'measure': 'Weight loss', 'timeFrame': 'at inclusion, 3 months, 6 months', 'description': '% weight loss'}, {'measure': 'BMI', 'timeFrame': 'at inclusion, 3 months, 6 months', 'description': 'BMI'}, {'measure': 'Blood albumin', 'timeFrame': 'at inclusion, 3 months, 6 months', 'description': 'Blood albumin'}, {'measure': 'Nutritional risk', 'timeFrame': 'at inclusion, 3 months, 6 months', 'description': 'Nutritional risk index'}, {'measure': 'Health beliefs associated with persistent symptoms', 'timeFrame': 'at inclusion, 3 months, 6 months', 'description': 'SSD-12 global score- may vary between 0 and 48 points - Each of the three psychological sub-criteria of DSM-5 somatic symptom disorder (cognitive, affective, behavioral) is measured by four items with all item scores ranging between 0 and 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = very often) Ratings are summed up to make a simple sum score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Randomized controlled trial', 'Cognitive behavior therapy', 'Physical exercise', 'Cognitive remediation', 'Post covid-19 condition'], 'conditions': ['Post COVID-19 Condition']}, 'referencesModule': {'references': [{'pmid': '33192483', 'type': 'BACKGROUND', 'citation': 'Alonso-Lana S, Marquie M, Ruiz A, Boada M. Cognitive and Neuropsychiatric Manifestations of COVID-19 and Effects on Elderly Individuals With Dementia. Front Aging Neurosci. 2020 Oct 26;12:588872. doi: 10.3389/fnagi.2020.588872. eCollection 2020.'}, {'pmid': '34312178', 'type': 'BACKGROUND', 'citation': 'Crook H, Raza S, Nowell J, Young M, Edison P. Long covid-mechanisms, risk factors, and management. BMJ. 2021 Jul 26;374:n1648. doi: 10.1136/bmj.n1648.'}, {'pmid': '32593341', 'type': 'BACKGROUND', 'citation': 'Varatharaj A, Thomas N, Ellul MA, Davies NWS, Pollak TA, Tenorio EL, Sultan M, Easton A, Breen G, Zandi M, Coles JP, Manji H, Al-Shahi Salman R, Menon DK, Nicholson TR, Benjamin LA, Carson A, Smith C, Turner MR, Solomon T, Kneen R, Pett SL, Galea I, Thomas RH, Michael BD; CoroNerve Study Group. Neurological and neuropsychiatric complications of COVID-19 in 153 patients: a UK-wide surveillance study. Lancet Psychiatry. 2020 Oct;7(10):875-882. doi: 10.1016/S2215-0366(20)30287-X. Epub 2020 Jun 25.'}, {'pmid': '34539470', 'type': 'BACKGROUND', 'citation': 'Gouraud C, Bottemanne H, Lahlou-Laforet K, Blanchard A, Gunther S, Batti SE, Auclin E, Limosin F, Hulot JS, Lebeaux D, Lemogne C. Association Between Psychological Distress, Cognitive Complaints, and Neuropsychological Status After a Severe COVID-19 Episode: A Cross-Sectional Study. Front Psychiatry. 2021 Sep 3;12:725861. doi: 10.3389/fpsyt.2021.725861. eCollection 2021.'}, {'pmid': '33181098', 'type': 'BACKGROUND', 'citation': 'Taquet M, Luciano S, Geddes JR, Harrison PJ. Bidirectional associations between COVID-19 and psychiatric disorder: retrospective cohort studies of 62 354 COVID-19 cases in the USA. Lancet Psychiatry. 2021 Feb;8(2):130-140. doi: 10.1016/S2215-0366(20)30462-4. Epub 2020 Nov 9.'}, {'pmid': '28069350', 'type': 'BACKGROUND', 'citation': 'Klem F, Wadhwa A, Prokop LJ, Sundt WJ, Farrugia G, Camilleri M, Singh S, Grover M. Prevalence, Risk Factors, and Outcomes of Irritable Bowel Syndrome After Infectious Enteritis: A Systematic Review and Meta-analysis. Gastroenterology. 2017 Apr;152(5):1042-1054.e1. doi: 10.1053/j.gastro.2016.12.039. Epub 2017 Jan 6.'}, {'pmid': '32777274', 'type': 'BACKGROUND', 'citation': 'Brascher AK, Schulz SM, Van den Bergh O, Witthoft M. Prospective study of nocebo effects related to symptoms of idiopathic environmental intolerance attributed to electromagnetic fields (IEI-EMF). Environ Res. 2020 Nov;190:110019. doi: 10.1016/j.envres.2020.110019. Epub 2020 Aug 7.'}, {'pmid': '15911910', 'type': 'BACKGROUND', 'citation': 'De Peuter S, Van Diest I, Lemaigre V, Li W, Verleden G, Demedts M, Van den Bergh O. Can subjective asthma symptoms be learned? Psychosom Med. 2005 May-Jun;67(3):454-61. doi: 10.1097/01.psy.0000160470.43167.e2.'}, {'type': 'BACKGROUND', 'citation': 'Graeupner D, Coman A. The dark side of meaning-making: How social exclusion leads to superstitious thinking. 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Cochrane Database Syst Rev. 2019 Oct 2;10(10):CD003200. doi: 10.1002/14651858.CD003200.pub8.'}, {'pmid': '25362239', 'type': 'BACKGROUND', 'citation': 'van Dessel N, den Boeft M, van der Wouden JC, Kleinstauber M, Leone SS, Terluin B, Numans ME, van der Horst HE, van Marwijk H. Non-pharmacological interventions for somatoform disorders and medically unexplained physical symptoms (MUPS) in adults. Cochrane Database Syst Rev. 2014 Nov 1;2014(11):CD011142. doi: 10.1002/14651858.CD011142.pub2.'}, {'pmid': '29313875', 'type': 'BACKGROUND', 'citation': 'Belleville S, Hudon C, Bier N, Brodeur C, Gilbert B, Grenier S, Ouellet MC, Viscogliosi C, Gauthier S. MEMO+: Efficacy, Durability and Effect of Cognitive Training and Psychosocial Intervention in Individuals with Mild Cognitive Impairment. J Am Geriatr Soc. 2018 Apr;66(4):655-663. doi: 10.1111/jgs.15192. Epub 2018 Jan 4.'}, {'pmid': '17726363', 'type': 'BACKGROUND', 'citation': "Wenisch E, Cantegreil-Kallen I, De Rotrou J, Garrigue P, Moulin F, Batouche F, Richard A, De Sant'Anna M, Rigaud AS. Cognitive stimulation intervention for elders with mild cognitive impairment compared with normal aged subjects: preliminary results. Aging Clin Exp Res. 2007 Aug;19(4):316-22. doi: 10.1007/BF03324708."}, {'pmid': '27833541', 'type': 'BACKGROUND', 'citation': 'Hallock H, Collins D, Lampit A, Deol K, Fleming J, Valenzuela M. Cognitive Training for Post-Acute Traumatic Brain Injury: A Systematic Review and Meta-Analysis. Front Hum Neurosci. 2016 Oct 27;10:537. doi: 10.3389/fnhum.2016.00537. eCollection 2016.'}, {'pmid': '25998261', 'type': 'BACKGROUND', 'citation': 'Mitolo M, Venneri A, Wilkinson ID, Sharrack B. Cognitive rehabilitation in multiple sclerosis: A systematic review. J Neurol Sci. 2015 Jul 15;354(1-2):1-9. doi: 10.1016/j.jns.2015.05.004. Epub 2015 May 9.'}, {'pmid': '30219036', 'type': 'BACKGROUND', 'citation': 'Ge S, Zhu Z, Wu B, McConnell ES. Technology-based cognitive training and rehabilitation interventions for individuals with mild cognitive impairment: a systematic review. BMC Geriatr. 2018 Sep 15;18(1):213. doi: 10.1186/s12877-018-0893-1.'}, {'pmid': '29200836', 'type': 'BACKGROUND', 'citation': 'Djabelkhir L, Wu YH, Vidal JS, Cristancho-Lacroix V, Marlats F, Lenoir H, Carno A, Rigaud AS. Computerized cognitive stimulation and engagement programs in older adults with mild cognitive impairment: comparing feasibility, acceptability, and cognitive and psychosocial effects. Clin Interv Aging. 2017 Nov 21;12:1967-1975. doi: 10.2147/CIA.S145769. eCollection 2017.'}, {'type': 'BACKGROUND', 'citation': "Pitron V. Vers un modèle cognitif bayésien du trouble à symptomatologie somatique [Thèse d'exercice]. [Paris]: Université Paris Descartes; 2017."}, {'pmid': '34312316', 'type': 'BACKGROUND', 'citation': 'Li J, Xia W, Zhan C, Liu S, Yin Z, Wang J, Chong Y, Zheng C, Fang X, Cheng W, Reinhardt JD. A telerehabilitation programme in post-discharge COVID-19 patients (TERECO): a randomised controlled trial. Thorax. 2022 Jul;77(7):697-706. doi: 10.1136/thoraxjnl-2021-217382. Epub 2021 Jul 26.'}, {'type': 'BACKGROUND', 'citation': 'McNair, D. M., & Kahn, R. J. (1983). Self-assessment of cognitive deficits. Assessment in geriatric psychopharmacology, 137, 143.'}, {'pmid': '15817019', 'type': 'BACKGROUND', 'citation': 'Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.'}, {'type': 'BACKGROUND', 'citation': "Van der Linden, M., Coyette, F., Poitrenaud, J., Kalafat, M., Calicis, F., Wyns, C., . . . Membres du GREMEM. (2004). L'épreuve de rappel libre/ rappel indicé à 16 items (RL/RI-16). In M. Van der Linden, S. Adam, A. Agniel, & Membres du GRENEM (Eds.), L'évaluation des troubles de la mémoire : présentation de quatre tests de mémoire épisodique avec leur étalonnage. (pp. 25-47). Marseille: Solal"}, {'pmid': '15010086', 'type': 'BACKGROUND', 'citation': 'Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. doi: 10.1016/S0887-6177(03)00039-8.'}, {'type': 'BACKGROUND', 'citation': "Godefroy, O, et le GREFEX (Groupe de Réflexion pour l'Évaluation des Fonctions Exécutives) (2008). Fonctions exécutives et pathologies neurologiques et psychiatriques. Évaluation en pratique clinique. Marseille : Solal."}, {'type': 'BACKGROUND', 'citation': "Majerus, S. (2008). La mémoire verbale à court terme : un simple produit des interactions entre systèmes langagiers, attentionnels et de traitement de l'ordre sériel. Psychologie Française, 53, 327-341."}, {'type': 'BACKGROUND', 'citation': 'Weschler, D. (2008). Weschler Adult Intelligence Scale (4th ed.). Peason.'}, {'pmid': '2124031', 'type': 'BACKGROUND', 'citation': 'Cardebat D, Doyon B, Puel M, Goulet P, Joanette Y. [Formal and semantic lexical evocation in normal subjects. Performance and dynamics of production as a function of sex, age and educational level]. Acta Neurol Belg. 1990;90(4):207-17. French.'}, {'type': 'BACKGROUND', 'citation': 'Giersky, F., & Ergis, AM. (2004). Les fluences verbales : aspects théoriques et nouvelles approches. Année Psychol, 104 : 331-360.'}, {'type': 'BACKGROUND', 'citation': "Brickenkamp, R., Schmidt-Atzert, L., & Liepmann, D. (2015). d2-R: test d'attention concentrée révisé: manuel. Hogrefe."}]}, 'descriptionModule': {'briefSummary': 'After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.\n\nThe primary objective of this study is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care.', 'detailedDescription': "After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment, and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential.\n\nThe primary objective is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care. The secondary objectives are to evaluate the evolution of the quality of life at 3 months, the evolution of the main persistent symptoms (fatigue, dyspnea, cognitive complaints, pain), the patients' satisfaction, the predictive and explanatory factors of the evolution.\n\nThis is a prospective randomized open-label study in two parallel arms: personalized multidisciplinary outpatient intervention versus usual care (waiting list). This 6-week program of care will include:\n\n* group education sessions including a psycho-education component (1 session / week)\n* a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test\n* if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): group cognitive and behavior therapy (2 sessions per week, including at least 1 in person).\n* if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having had an initial episode of symptomatic COVID-19 according to one of the following criteria:\n\n * SARS-Cov-2 PCR +\n * SARS-Cov-2 + antigenic test\n * SARS-Cov-2 + serology\n * Prolonged anosmia/ageusia of sudden onset\n * Typical chest CT scan\n* Still having at least one of the initial symptoms and possibly new symptoms including fatigue, dyspnea, cognitive impairment or pain beyond 4 weeks after the onset of the acute phase of the disease.\n* These initial and persistent symptoms are not better explained by another diagnosis not known to be related to Covid-19.\n* These symptoms are the cause of an alteration in quality of life and global functioning deemed significant by the patient.\n* Having an indication to either supervised exercise and / or cognitive behavior therapy and / or cognitive remediation Exclusion Criteria\n* Medical emergency requiring management not compatible with research\n* Neuropsychiatric disorder likely to alter cognitive functions, prior to the Covid-19 episode\n* Medical contraindication to exercise training such as pericarditis or progressive myocarditis\n* Patient under state medical assistance\n* Patient who does not speak French\n* Pregnancy in progress'}, 'identificationModule': {'nctId': 'NCT05532904', 'acronym': 'ECHAP-COVID', 'briefTitle': 'Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID)', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Evaluation and Comparison of Multidisciplinary Day-hospital Versus Waiting List Management of Persistent Symptoms After an Acute Episode of COVID-19', 'orgStudyIdInfo': {'id': 'APHP220357'}, 'secondaryIdInfos': [{'id': '2022-A00268-35', 'type': 'OTHER', 'domain': 'ID-RCB Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'This 6-week program of care will include:\n\n* group education sessions including a psycho-education component (1 session / week)\n* a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test.\n* if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): a group protocol of cognitive and behavior therapy (2 sessions per week, including at least 1 in person).\n* if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)', 'interventionNames': ['Behavioral: Personalized multidisciplinary day-hospital intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual care (waiting list)'}], 'interventions': [{'name': 'Personalized multidisciplinary day-hospital intervention', 'type': 'BEHAVIORAL', 'description': 'This 6-week program of care will include:\n\n* group education sessions including a psycho-education component (1 session / week)\n* a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test.\n* if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): a group protocol of cognitive and behavior therapy (2 sessions per week, including at least 1 in person).\n* if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'Hôtel Dieu Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Cédric Lemogne, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP and Université Paris Cité'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'URC-CIC Paris Descartes Necker Cochin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}